Drugs@FDA: FDA-Approved Drugs

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New Drug Application (NDA): 018557
Company: ROCHE

Products on NDA 18557

Drug Name	Active Ingredients	Strength	Dosage Form/Route	Marketing Status	TE Code	RLD	RS
FANSIDAR	PYRIMETHAMINE; SULFADOXINE	25MG;500MG	TABLET;ORAL	Discontinued	None	No	No

Labels for NDA 018557

Action Date	Submission	Supplement Categories or Approval Type	Letters, Reviews, Labels, Patient Package Insert	Note	Url
02/26/2004	SUPPL-15	Labeling	Label (PDF)		https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/18557slr015_fansidar_lbl.pdf